Ge Healthcare It: Medical Device Recall in 2014 - (Recall #: Z-0773-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image and interpretations. Mammongraphic may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.

Product Classification:

Class II

Date Initiated: March 4, 2011

Date Posted: January 22, 2014

Recall Number: Z-0773-2014

Event ID: 64740

Reason for Recall:

In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounted for. These versions of Imagecast PACS look for values to be present in the following tags to calculate a measurement from pixels to millimeters (mm): (0020,0030) Pixel Spacing and, (0018,1164) Imager Pixel Spacing. Because the estimated magnification factor is not used, distance meas

Status: Terminated

Product Quantity: 43 units

Code Information:

Imagecast PACS versions prior to 3.6.51.01

Distribution Pattern:

Nationwide Distribution: US including states of: AL, AZ, CT, FL, GA, IA, IN, LA, MA, MI, MN, MO, NC, NH, NJ, NY, OH, PA, TX, VA, WI, WV + District of Columbia.

Voluntary or Mandated:

Voluntary: Firm initiated